Genzyme wins FDA approval for multiple sclerosis treatment

Wednesday, September 12, 2012 -- Anonymous (not verified)

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Healthcare

Wednesday, September 12, 2012

Author(s):

herald.staff

Cambridge-based Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration has approved Aubagio as a new once-daily, oral treatment for patients with relapsing forms of multiple sclerosis.Aubagio has proven to reduce relapses, slow the progression of physical disability and reduce the number of brain lesions as detected by MRI.

"We are very excited to introduce Aubagio as a new treatment option that can make a difference in the lives of people with multiple sclerosis," said David Meeker, president and CEO of Genzyme. "The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community."

"Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly," said Aaron E. Miller, medical director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center. "The FDA’s approval of Aubagio, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease."

The ongoing Aubagio clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

"We are greatly encouraged to see a new oral therapeutic option become available to people living with MS," said Timothy Coetzee, chief research officer at the National MS Society. "With collaborative research under way around the world today, this is an extremely hopeful time for anyone who is diagnosed with MS."

The Aubagio label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data).

In MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo-treated patients. The most common adverse events associated with Aubagio in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.